EU-GMP Project Lead

Purplefarm; Fredericton; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Training & development

Team-oriented culture

Job summary

PURPLEFARM is seeking an EU-GMP Project Lead to oversee certification activities and coordinate across QA, regulatory, and operations to ensure compliance with EU-GMP standards.

Responsibilities include leading certification projects, maintaining inspection readiness, and developing compliant quality documentation across the site. This role requires strong leadership and regulatory experience in cannabis quality systems.

Qualifications

• Bachelor’s degree in a science discipline or equivalent experience.
• 3–5 years of QA in regulated industry with EU-GMP exposure.
• Strong knowledge of EU-GMP, Health Canada Cannabis Regulations, ICH guidelines.

Responsibilities

• Lead EU-GMP certification activities and coordinate certification projects.
• Serve as quality representative for inspections and regulatory interactions.
• Review quality systems and documents for EU-GMP alignment.

Skills

Quality assurance

Regulatory compliance

EU-GMP knowledge

Leadership

Documentation control

Education

Bachelor’s degree in Science/Pharmacy

Tools

eQMS

MS Office

Job description

The Role

The EU-GMP Project Lead will lead and coordinate activities related to achieving and maintaining EU-GMP certification, serving as a key quality representative for certification projects, inspections and regulatory interactions.

Responsibilities

• Lead and coordinate all activities related to achieving and maintaining EU-GMP certification.
• Serve as the primary quality representative for EU-GMP certification projects, inspections and regulatory interactions.
• Review quality systems, procedures and records for alignment with EU-GMP requirements.
• Conduct gap assessments and develop remediation plans to address deficiencies.
• Collaborate cross-functionally to implement EU-GMP-compliant processes and practices.
• Develop, revise and approve quality documents including SOPs, validation protocols, reports and quality agreements.
• Oversee and support qualification and validation activities for equipment, utilities, computerized systems, cleaning and processes.
• Coordinate and participate in internal audits and inspection-readiness activities.
• Track CAPAs arising from audits, assessments and compliance reviews.
• Support supplier and service-provider qualification activities.
• Ensure training programs meet EU-GMP requirements and coordinate related training.
• Review quality metrics and compliance trends and participate in quality risk-management activities.
• Support batch-record review and quality oversight activities required for EU-GMP compliance.
• Support development and maintenance of the Site Master File and other regulatory documentation.
• Monitor updates to EU-GMP regulations, guidelines and industry best practices.
• Support compliance with the Cannabis Act, its Regulations and applicable provincial cannabis regulations.
• Prepare and support responses to audit observations, inspection findings and regulatory commitments.
• Provide regular updates to the COO on certification progress, compliance risks and project milestones.
• Act as a subject matter expert on EU-GMP requirements and provide guidance across departments.
• Perform other duties as assigned.

Key Deliverables

• Successful EU-GMP certification and inspection outcomes.
• Closure of identified EU-GMP gaps and CAPAs.
• Completion of validation and qualification programs.
• Inspection-ready quality documentation and records.
• Ongoing compliance with EU-GMP standards and expectations.
• Development of a sustainable EU-GMP quality culture across the organization.

Qualifications

• Bachelor's degree in Science, Pharmacy, Microbiology, Chemistry, Biology or a related discipline, or an equivalent combination of education and experience.
• 3-5 years of Quality Assurance experience in a regulated industry, with direct involvement in EU-GMP/GMP quality systems.
• Knowledge of EU-GMP, Health Canada Cannabis Regulations, Good Production Practices (GPP) and ICH guidelines.
• Experience supporting or leading EU-GMP certification projects, regulatory inspections, customer audits and CAPA management.
• Strong understanding of change control, deviations, investigations, risk assessments, document control, validation, supplier qualification and training.
• Experience reviewing and approving controlled documents, batch records, SOPs, validation protocols and quality records.
• Excellent organizational, analytical and problem-solving skills.
• Strong communication and leadership skills with cross-functional experience.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).
• Ability to work independently with strong attention to detail, integrity and commitment to continuous improvement.

What You Can Expect at PURPLEFARM

At PURPLEFARM, our people are part of how we grow. We offer opportunities to learn, take on new responsibilities and contribute across a growing organization.

Competitive Compensation & Benefits

Competitive compensation and employee benefits for eligible positions.

Learn & Grow

Opportunities for hands‑on training, cross‑training and developing new skills as part of your role.

Work as a Team

A collaborative environment where cultivation, operations, quality and other teams work together.

Make an Impact

The opportunity to contribute to how we grow, improve our processes and build what comes next at PURPLEFARM.

Safety & Quality

A workplace built around established procedures, quality standards and a commitment to working safely.

PURPLEFARM is an equal opportunity employer. Applicants may request accommodation during the screening or interview process.